What's New on the FDA Drugs Site
December 16, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA announces Pharmacy Compounding Advisory Committee members
- Orange Book (updated)
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)
New and Generic Drug Approvals
December 15, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abilify | aripiprazole | Tablet;Oral | Otsuka | Manufacturing Change or Addition |
| Argatroban | argatroban | Injectable;Injection | Teva Pharms Usa Inc | Approval |
| Brevital Sodium | methohexital sodium | Injectable;Injection | Par Sterile Products | Manufacturing Change or Addition |
| Cyklokapron | tranexamic acid | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Egrifta | tesamorelin acetate | Powder;Subcutaneous | Theratechnologies | Manufacturing Change or Addition |
| Ellence | epirubicin hydrochloride | Injectable;Injection | Pfizer Inc | Labeling Revision |
| Exparel | bupivacaine | Injectable, Liposomal;Injection | Pacira Pharms Inc | Manufacturing Change or Addition |
| Firmagon | degarelix acetate | Powder;Subcutaneous | Ferring | Manufacturing Change or Addition |
| Intralipid 10% | soybean oil | Injectable;Injection | Fresenius | Manufacturing Change or Addition |
| Jakafi | ruxolitinib phosphate | Tablet;Oral | Incyte Corp | Labeling Revision |
| Kerydin | tavaborole | Solution;Topical | Anacor Pharms Inc | Manufacturing Change or Addition |
| Marcaine Hydrochloride | bupivacaine hydrochloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Marcaine Hydrochloride Preservative Free | bupivacaine hydrochloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Marcaine Hydrochloride W/ Epinephrine | bupivacaine hydrochloride; epinephrine bitartrate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Marcaine Hydrochloride W/ Epinephrine Preservative Free | bupivacaine hydrochloride; epinephrine bitartrate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Signifor Lar | pasireotide | Suspension; Injectable, Intramuscular | Novartis Pharms Corp | Approval |
| Tamiflu | oseltamivir phosphate | Capsule;Oral | Roche | Manufacturing Change or Addition |
| Today | nonoxynol-9 | Sponge;Vaginal | Mayer Labs Inc | Manufacturing Change or Addition |
| Xopenex | levalbuterol hydrochloride | Solution;Inhalation | Oak Pharms Inc | Manufacturing Change or Addition |
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